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Artificial Heart Buys Time Until Transplant

Study Shows It Benefits Patients Waiting for Donor Heart

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1 in 4 Dies Waiting for Donor Heart continued...

"The way to look at this is this is one small step in treating end-stage heart failure, but from a technology point of view, it's a major step," he tells WebMD. "Ultimately, the goal is to develop a technology that not only will bridge a patient to transplant, but for some patients who will never get a transplant to develop a platform that could be utilized for longer-term therapy. But like everything in science, you have to walk before you run."

For the study, the research team at the Sarver Heart Center at the University of Arizona tracked 81 patients over nine years who received an artificial heart. They also observed a comparison group of 35 others who didn't get the artificial heart.

Some of the researchers, like Slepian, are also officers of SynCardia Systems, Inc., of Tucson, the makers of the CardioWest Total Artificial Heart.

One year after receiving the artificial heart, 70% of those getting the device were still alive, compared with only 31% of those in the comparison group. Sixty-six percent of patients in the implanted group were still alive after five years, the researchers report.

Advantage Over Current Treatments

With heart failure, the heart's main pumping chambers -- or ventricles -- become too weak to pump blood. Currently, doctors implant a device in some patients called a "ventricular assist device" to help the heart pump blood. But when both of the heart's pumping chambers fail, these devices may not be effective.

But the artificial heart may be a solution for these patients. To implant the device, surgeons cut off the bottom half of the heart and sew the artificial heart onto the top chambers; it's then powered by a large, washing machine-sized air generator to keep blood pumping until an actual heart can be transplanted. A smaller, more portable unit is being developed to allow patients more mobility following implantation, says Slepian.

Still, his study shows that the artificial heart malfunctioned in 17% of patients, causing death in one patient. The device also resulted in infection in 77% and bleeding in 62%. Fitting the bulky device proved troublesome in 5%, and about one-third developed respiratory problems.

Most of these complications were minor, says Slepian, but had to be noted for the FDA panel review. "If they had a slight temperature bump, we noted it as an infection, but nothing was life-threatening," he tells WebMD.